I. Field of the Invention
The present invention provides data manipulation and analysis systems and methods associated therewith. In particular, the present invention is directed to systems useful for analyzing medical data related to clinical pathways and performing actions based upon the analyses.
II. Background of the Invention
Escalation of medical costs has led to attempts in the past to streamline systems for providing medical care. Attempts to control such costs have heretofore been thwarted by inexact methods of gathering statistical information relevant to the medical care of interest. Certainly, rudimentary systems for tracking patient information have been developed. Moreover, patient treatment information has also been tracked and stored for further analysis. However, to date, there have not been systems for continuously tracking patient information and patient treatment information, such as clinical pathways for the patient, incorporating these into a useful form, and reacting in an automated fashion according to the recorded information. Therefore, consistent with the goal of providing cost-effective medical care, there remains a need for integrated systems capable of tracking and analyzing medical treatment information.
As an example, home health care is expected to account for an ever-increasing amount of medical care to be provided over the coming years. Therefore, cost reduction systems applicable to the home care setting are similarly highly desirable and yet are, heretofore, virtually unknown.
Similarly, there exists a need for effective data tracking and manipulation vital to providing "stable acute" care, as that term is defined and used herein. Historically, patients who had surgery would have to come to the hospital anywhere from one to three days early. After surgery, they would then spend significant time in the hospital and, in years past, these patients would actually be kept in the hospital and on bed rest for a lengthy stay. The operative patient's stay can be broken down to three phases: pre-operative, operative and post-operative. Each of these phases has changed drastically over the years.
During the pre-operative time period, patients historically came to the hospital anywhere from one to three days prior to surgery. Early arrival at the hospital usually was required for patients undergoing abdominal procedures because of the necessary to perform a bowel prep believed to be necessarily done in the hospital. This has changed because patients now can receive an equivalent bowel prep in their own home before coming to the hospital. However, although the bowel prep may be equally effective in cleaning out the intestine, the home prepared patients often become dehydrated. Yet pressures from managed care to save money have forced the medical community to ignore the fact that these patients are often dehydrated.
Additionally, even those patients not needing a bowel prep used to come in one day prior to surgery. A history and physical would be done the night before surgery and then the pre-op, including anesthesia visit and various x-rays and blood tests, would be done prior to the operation. This, too, has changed in that the history and physical is now done in the doctor's office and the pre-op, including the anesthesia visit, laboratories and x-rays, are now done a number of days prior to the operation. Again, the pressures of managed care have reduced the prior one to three day in-hospital pre-operative period to the current practice of admission to the hospital early in the morning of surgery.
Economic pressures have recently forced movement toward minimizing any pre-operative stay. For similar reasons, it would be desirable to minimize post-operative in-hospital stays. One example of the result of this desire is the so-called "drive through mastectomy," which permits discharge from the hospital within 24-36 hours after abdominal hysterectomy or laparoscopic procedures. Unfortunately, in major abdominal procedures, there are great limitations to sending patients home early. These limitations are present for any major procedure requiring an abdominal incision (such as in gynecological oncology, radical hysterectomy, lymph node sampling or debulking, urology, radical prostatectomy, nephrectomy through abdominal approach, general surgical procedures including colectomy, small bowel resection with abdominal approach, or gastrectomy). Once there has been significant manipulation of the intestines after an abdominal incision, there are tremendous limitations to sending the patients home prior to demonstration of gastrointestinal ("GI") function, an event which can easily take four to seven days to occur.
In the operative period, there are many changes that have occurred in the past few years. For instance, the suture materials used today cause much fewer adverse reactions and are much more secure. Staple devices have increased the speed of the operative procedures as well as providing more security resulting in less problems post-operatively. For example, colectomies are now done with staple anastomoses thereby minimizing the likelihood of a leak of stool through the anastomosis is minimal. This, of course, effects the post-operative time period because fewer complications are expected and observed compared to the past. Finally, operative procedures have been significantly refined and improved, which also aids in shorter operating room ("OR") time and less post-op complications.
The post-operative period has seen many changes and improvements over the years, including quicker ambulation of the patient, decreased bed rest, knowledge that faster discharge probably decreases likelihood of venous thrombosis and hospital acquired infections, and understanding that many post-operative situations do not necessitate long hospital stays. For example, patients who had mastectomies used to stay in the hospital for four to five days until the drain stopped yielding fluid. Presently, patients with mastectomies can go home within the first 24 hours of surgery and are taught how to take care of the drains at home. However, there are patients who have had mastectomies who have no care giver at home, yet are expected to take care of the drains, pain, any questions and any emotional discomfort without any assistance. Other improvements include decreased use of nasogastric tube after gastrointestinal procedures including small bowel resection or large bowel resection, use of patient controlled analgesia as opposed to injections which allows the patient to manage his or her pain more easily at home, development of intravenous computerized monitors which prevent against possible IV errors, use of sequential hose which are stockings which blow up on the legs in a sequential manner and significantly decrease the likelihood of thrombosis, use of H2 blockers (Histamine-2 blockers) such as PEPCID.RTM., TAGAMET.RTM., and ZANTAC.RTM. in the post-operative setting to significantly decrease the chance of gastric bleeding or other upper GI complications, use of home care for either the chronically ill post-operative patients or the generally chronically ill patient, and the use of improved IV antibiotics to decrease post-operative infections.
Over the past ten to fifteen years, home care has also become a viable option. However, although home care has been quite successful in the past with patients, home care has only been known for handling patients classified as chronically ill or, very recently, for handling patients who would usually come to the emergency room. For a chronically ill patient, the patient remains in the hospital for a long period of time. While it may take 24-48 hours to send the patient home, the stay at home may vary from as much as two weeks to a few months.
Hospital length of stay and other clinical pathways are ultimately the purview of the physician. However, certain guidelines exist, such as those published under the title Milliman & Robertson Healthcare Management Guidelines by Milliman & Robertson, Inc., Actuaries & Consultants. These guidelines are gathered manually by physicians and nurses based on their collective judgment of suitable care. The gathering process is tedious and subjective. The resulting "standards" are developed not through the collection and analysis of actual data (such as would be done in preparing, for example, life insurance mortality tables), but instead are developed by committees of clinicians and others who are hired by actuarial companies and asked their subjective opinions. Therefore, these exists a need for an automated system to determine optimal treatment steps so as to improve important factors such as length of post-operative stay and recovery.
For example, the post-operative hospital stay standard for a woman after an abdominal hysterectomy is set today by such a committee. It is referred to as the "optimal" hospital stay for this procedure. If described as a 5-day post-op hospital stay, there are events during the stay that are looked for and flagged, such as a bowel movement. However, there is no data or supporting analysis that concludes that such a woman must remain in the hospital for yet another day if she has not had a bowel movement. It is simply unknown whether a bowel movement truly is a statistically significant variable or event. Rather, in prior art systems, the committee of clinicians, or others, simply make a best guess that this is a significant factor.
Because of economic pressures, it is highly desirable to provide an optimized post-operative discharge program. Additionally, it is highly desirable to provide a system capable of decreasing infection and decreasing the incidence of, for example, venous thrombosis by permitting early discharge.
The post-operative period has changed dramatically over the years from a very lengthy stay only in the hospital to using procedures that allow patients to go home sooner, such as laparoscopically assisted procedures, as well as refining various procedures so as not to require lengthy stays. Again, many of these procedures are procedures that do not require an abdominal incision and yield no problem with post-operative bowel function. In essence, the post-operative stay has already deviated somewhat from the hospital setting to the home.
Using the example of the "drive through mastectomy", the patient has had a complex procedure which may often take up to three or more hours and has suffered a large incision. These patients are nonetheless released from the hospital because the incision is a high one which does not impair their breathing. In addition, because the patient does not have an abdominal incision, there is a low likelihood of any bowel dysfunction. However, a number of problems can still occur. First, the fairly large incision may impart a significant amount of pain for the patient, yet the patient is released with only oral medication while the patient may, in fact, require patient controlled analgesics (e.g., intravenous type medications such as MORPHINE.RTM. or DEMERAL.RTM.). The patient has also had a very lengthy procedure and depending on the type of anesthesia used, may have some residual anesthesia effects, which could include nausea. The patient may require an IV antiemetic (anti-nausea agents) or intravenous fluids to aid in diminishing the nausea. Many of these patients not only have a long incision with a dressing which could leak or become infected, but they also have one or more drains in place. The patients are instructed in how to use these drains but this can be cumbersome or not entirely understood by the patient.
Moreover, once released, the physician loses track of the patient except for phone calls initiated by the patient to the physician, which may be difficult for many reasons. First, many physician phone calls during the day do not actually reach the physician but rather go to his or her staff. During the evening, the physician may not receive knowledge of the phone call whatsoever and the patient may be forced to go to the emergency room. Therefore, it would be highly desirable to have a system permitting the capability to provide home care and direct information communication to the physician and his or her staff in real time, so as to reduce the recovery period and the risk of complications.
Other patients who are rapidly discharged are post abdominal hysterectomy patients. Often these patients have low transverse incisions which again do not yield significant problems for breathing. However, bowel dysfunction problems may still exist. Patients sometimes have difficulty taking down liquids or food for as many as three or four days. Unfortunately, these patients are sent home after post-op day one to one and a half and, at that time, with current systems, do not have any way of receiving IV fluids in the event they have nausea or difficulty taking in fluids. Additionally, if they have any significant discomfort, they are only on oral medications which may not be potent enough. Therefore, there exists a need for systems and methods for permitting expeditious and appropriate post-operative discharge, while maintaining the capability of providing an appropriate level of care to the patient while the patient continues to recover.
A third example of early discharge includes patients who have had gastrointestinal procedures. Patients with colectomies, after demonstrating the ability to take in fluids without developing abdominal distention, may be discharged from the hospital. These patients remain at risk for developing bowel dysfunction, abdominal distention, and possible major complications such as leakage from a bowel anastomosis. In present day systems, they are nevertheless sent home without any significant continued communication with the doctor or any prearranged skilled nursing care. A tremendous risk exists the patient could become ill and severely dehydrated and require a lengthy stay in the hospital upon re-admission. In some areas of the country, such discharges do not occur because physicians oppose it. There exists a need for a system able to permit such discharged patients to remain safely in the home without the attendant risks described above.
As stated previously, actuarial companies serving the health care industry today do not make recommendations to their customers (e.g., insurance companies, etc.) based upon their analysis of large collections of data as they would in other industries (e.g., life insurance), but instead use subjective, and potentially inaccurate, committees. One reason why this is true might be that actuarial companies simply have not created, nor have access to, the large amounts of data and processes needed to perform such analysis. While others have collected health care data previously, no databases exist whereby the data is organized in such a way so as to enable meaningful analysis of the data, and no processes exist to analyze such data.
The above background describes some pre-existing mechanisms by which patients are released to the home for part of their post-operative period. Each of these mechanisms suffers from drawbacks and is, in some way, not satisfactory in comparison to the use of the present invention as a way to provide appropriate post-operative care to patients, including stable acute patients. The foregoing evidences the significant difficulties and shortcomings of known systems.